Contents:

1. Overview 6 1.1 Statement of Report 6 1.2 Scope of the Report 8 1.3 Objectives 8 1.4 Methodology 9 1.5 Executive Summary 10 2. Overview of Diagnostic Point of Care Testing 11 2.1 Key Issues in the Point of Care Diagnostic Testing Sector 11 2.1.1 Current Market Trends and Drivers 11 2.1.2 Effectiveness of POCT 12 2.1.3 New Growth Areas for POCT 13 2.1.4 Advantages of POCT in a Clinical Setting 13 2.1.5 Pricing and Reimbursement Issues 13 2.1.6 Key Customer Segments 13 2.2 Global Point of Care Marketplace 13 2.3 Shifts from Central-Lab Testing to POCT 15 2.4 Geographical Distribution 15 2.5 Emerging New Technologies 16 2.6 Challenges of POCT 17 2.7 Key Issues for POCT 17 2.7.1 Locations of POCT 17 2.7.2 Hospital Lab Rapid Tests 18 2.7.3 Doctor's Office Laboratory 18 2.7.4 Non-Hospital POCT 18 2.7.5 Home Monitoring 19 2.7.6 Milestones in Technology Development 20 2.7.7 Drive for Decentralization from Lab to Patient 20 2.7.8 Expanded Reimbursement 20 2.7.9 Competitive Landscape for POCT 23 2.8 The Future of POCT 23 3. POC and Rapid Testing: Market Analysis: Size, Background, Growth, Share and Competitors 24 3.1 Global POCT Market 26 3.2 U.S. Point of Care Markets 27 3.3 European POCT Market 33 3.4 Japanese POCT Market 35 4. The Place of POCT in Critical Care 36 4.1 Technological Diversity in POCT 36 4.1.1 The Wide Range of Point of Care Assays 36 4.1.2 Challenge of Testing on a Single Platform 39 4.1.3 Connectivity with Testing Platforms 40 4.1.4 Improvement in Clinical Outcomes with Use of POCT 42 4.1.5 Future Developments 42 4.2 Point of Care Addresses Critical Requirements 43 4.2.1 Needs in Critical-Care Testing 43 4.2.2 Point of Care Instrument Key Elements 44 4.2.3 Key Advancements-Menu, Quality Assurance (QA), Connectivity, Internet Access 44 4.2.4 Standardized System for All Testing Locations 45 4.3 POCT Versus Central-Laboratory Testing 47 4.3.1 The Financial Advantages of POCT 47 4.3.2 Is the Shift Towards Point of Care Justified? 47 4.3.3 Overall Cost Benefit 48 4.3.4 More Available Time for Clinical Practitioners 49 4.3.5 Future Policies 49 5. POCT Sector Trends and Forecasts 50 6. Business Trends in the Point of Care Sector 52 6.1 Sector Consolidation 52 6.2 Acquisition, License Agreements, Internal Development and Partnerships 53 6.3 Product Breadth in POCT 55 6.4 Companies Exiting from POCT 55 6.5 Increased Market Penetration 56 6.6 Costs of Doing Business in Europe 57 6.7 Drivers of European Diagnostics Testing 57 6.8 European Reimbursement Practices 57 6.9 Cost Containment in Europe 57 6.10 Significant Factors that Provide Competitive Advantage 57 6.11 Sales and Marketing Strategies for POCT 58 6.11.1 North American Market 58 6.11.2 International Markets 59 6.11.2.1 Europe 59 6.11.2.2 Central and South America 60 6.11.2.3 Asia/Pacific 60 7. Biotechnology Industry Trends 61 7.1 Pharmaceutical Industry Trends 61 7.2 Acquisition, License Agreement and Partnerships 62 8. Government Regulation 63 8.1 Government Regulation 63 8.1.1 U.S. Regulation 63 8.1.1.1 Importing Medical Devices into the U.S. 64 8.1.1.2 Exporting Medical Devices from the U.S. 65 8.1.2 U.K. Regulations 66 8.1.3 E.U. Regulations 67 8.1.4 Japanese Regulations 69 8.1.5 Korean Regulations 70 8.2 Post-Filing Regulations for Point of Care Devices 70 8.3 Exporting Unapproved POCTs 71 8.4 Analyte Specific Reagents (Home-Brew Tests) 71 8.5 Medical Device Registration 72 8.6 Product Labeling 72 8.7 Punitive FDA Actions 72 8.8 Clinical Laboratory Improvement Act of 1988 and State Laboratory Laws 72 8.9 Impact of Regulations on the Industry 73 8.10 Minimizing Regulatory Barriers 74 9. Limited Reimbursements by Third-Party Payers Obstruct Sales 77 9.1 Third-Party Reimbursement Impact on POCT Reagents and Devices Sales 77 9.2 Reimbursement Codes Classification 77 9.3 Point of Care Product Line Reimbursement Picture 78 10. Barriers to Business 79 10.1 Concentration of Customers 79 10.2 Intense Competition from Other Companies 79 10.3 Protection of Intellectual Property Rights 79 10.4 Physician Acceptance 80 10.5 Current Levels of Growth in the Market for Point of Care Diagnostic Testing Procedures May Not be Indicative of Future Growth 80 10.6 Additional Applications of Technology Platform 81 10.7 Management of Growth 81 10.8 Difficulty of Establishing a Marketing Infrastructure 81 11. Acquisition Activity 82 11.1 The Ideal Acquisition Profile 82 11.2 Markets of Interest for Acquisition of POCT 82 11.3 Key M&A Steps 82 12. Company Profiles 83 12.1 Abaxis, Inc. 83 12.2 Abbott Diagnostics 85 12.3 Accumetrics, Inc. 88 12.4 Accurex Biomedical, Pvt., Ltd. 88 12.5 Akers Bioscience (ABI) 88 12.6 Alfa Scientific Design, Inc. 89 12.7 Ambri, Ltd. 89 12.8 American Bio Medica Corp. 89 12.9 Ani Biotech 91 12.10 Apogent Technologies 91 12.11 Ark Therapeutics 91 12.12 ARKRAY 92 12.13 Atlas Genetics 92 12.14 Atonomics 92 12.15 Avox Systems 92 12.16 Axis-Shield 92 12.17 Bayer Corp. 93 12.18 Beacon Diagnostics 95 12.19 Beckman Coulter 95 12.20 Binax Corporation 100 12.21 Biomerica 100 12.22 BioMérieux Vitek, Inc. 101 12.23 BioScan Screening Systems, Inc. 101 12.24 Biosite Diagnostics 101 12.25 BioStar 101 12.26 British Biocell Holdings 101 12.27 Caliper Life Sciences 102 12.28 Calypte Biomedical 103 12.29 Cardiovascular Diagnostics 104 12.30 Chembio Diagnostics 104 12.31 Cholestech 104 12.32 CompuCyte Corporation 104 12.33 Cozart Bioscience 104 12.34 Cygnus Therapeutic Systems 105 12.35 Cytogen 105 12.36 Dade Behring 105 12.37 Daiichi Sankyo Group 105 12.38 Denka Seiken Co., Ltd. 106 12.39 Diagnostic Chemicals, Ltd. 106 12.40 EY Laboratories, Inc. 106 12.41 Enterix, Inc. 107 12.42 Focus Diagnostic, Inc. 107 12.43 GDS Technology 107 12.44 GenBio 107 12.45 Genzyme Diagnostics 107 12.46 Grant Life Sciences, Inc. 110 12.47 Gryphus Diagnostics, LLC 110 12.48 Guided Therapeutics, Inc 110 12.49 Helena Laboratories 111 12.50 Hema Diagnostic Systems 112 12.51 HemoCue, Inc. 112 12.52 Home Access Health Corp. 113 12.53 i-STAT Corporation 113 12.54 ImmunoScience, Inc. 114 12.55 Instrumentation Laboratory 115 12.56 International Medical Innovations 115 12.57 Inverness Medical Innovations 115 12.58 Johnson & Johnson 120 12.59 LifeAssays 122 12.60 LifePoint, Inc. 122 12.61 Lifestream Technologies 122 12.62 LXN Corp. (Inverness Medical Technologies) 122 12.63 Matritech 122 12.64 Medical Services International, Inc. 123 12.65 MediSense 123 12.66 Medisys 124 12.67 Medix Biochemica 124 12.68 MedMira Laboratories 124 12.69 Meretek Diganostics Group 126 12.70 Meridian Bioscience 126 12.71 MiniMed 128 12.72 Mitsubishi Chemical USA, Inc. 128 12.73 Mitsubishi Kagaku Iatron 129 12.74 Nanogen 129 12.75 New Horizons Diagnostics 131 12.76 Nova Biomedical 132 12.77 OraSure 134 12.78 Orgenics 136 12.79 Orion Diagnostica 137 12.80 PanBio, Ltd. 137 12.81 Phamatech Corporation 137 12.82 PharmaNetics, Inc. 137 12.83 Phillips Medical Systems 138 12.84 Polymedco 139 12.85 Polymer Technology Systems 140 12.86 Princeton BioMeditech Corporation 140 12.87 Quest Diagnostics 140 12.88 Quidel 141 12.89 Radiometer 145 12.90 Response Biomedical Corp. 147 12.91 Roche Diagnostics 148 12.92 Royal Philips Electronics 150 12.93 Saliva Diagnostics 151 12.94 Savyon Diagnostics 151 12.95 Selfcare, Inc. 152 12.96 Shanghai Siic Kehua Biotech Co., Ltd. (Kehua Biotech) 152 12.97 Shionogi & Co., Ltd. 152 12.98 Siemens Corporation 152 12.99 SpectRx, Inc. 153 12.100 Spectral Diagnostics 154 12.101 StatSure Diagnostics 154 12.102 STC Technologies 155 12.103 Strategic Diagnostics 155 12.104 Sun Biomedical Laboratories 155 12.105 Sybron International Corporation 155 12.106 TheraSense, Inc. 155 12.107 Thermo BioStar 155 12.108 Thoratec/International Technidyne Corp. 156 12.109 Trinity Biotech, PLC 157 12.110 Väsamed, Inc. 159 12.111 Venkateshwara Hatcheries Pvt., Ltd. 160 12.112 Wampole Laboratories 160 12.113 Worldwide Medical Corporation 160 13. FDA Currently-Waived Tests 161 INDEX OF TABLES Table 2.1: POCT Frequency in Hospitals 14 Table 2.2: Worldwide Distribution of IVD Testing in 2007 16 Table 2.3: Top Twelve Country IVD Testing Markets, 2007 16 Table 2.4: Competitive Landscape for Point of Care Diagnostic Testing 23 Table 3.1: Actual Reported Number of Emergency Room Visits in U.S. Hospitals, 1997-2005 24 Table 3.2: Number of POCTs in U.S., 2004-2012 24 Table 3.3: The Overall IVD Testing Market Worldwide, 2007 25 Table 3.4: Largest Diagnostic Companies Worldwide, 2007 26 Table 3.5: Global Point of Care Revenues, 2005-2012 27 Table 3.6: Worldwide Distribution of POCT, 2007 27 Table 3.7: U.S. POCT Market, 2000-2012 28 Table 3.8: U.S. Clinical Laboratory Diagnostic Test Market Segments by Location of Analysis, 2007 28 Table 3.9: U.S. POCT by Performance Location, 2007 28 Table 3.10: U.S. Clinical Diagnostic POCT and Rapid Test Market Segments, 2007 29 Table 3.11: U.S. POCT Glucose Testing Market, 2003-2012 29 Table 3.12: U.S. POCT Blood Gas and Electrolytes Market Size, 2003-2012 30 Table 3.13: U.S. POCT Coagulation Market Size, 2003-2012 30 Table 3.14: U.S. POCT Cardiac Markers Market Size, 2003-2012 30 Table 3.15: U.S. POCT Dedicated Primary Care Markers Market Size, 2003-2012 31 Table 3.16: U.S. POCT Urinalysis Market Size, 2003-2012 31 Table 3.17: Manufacturer Market Share U.S. POCT Market, 2007 31 Table 3.18: Manufacturer Market Share U.S. POCT Market Glucose Testing, 2007 32 Table 3.19: Manufacturer Market Share U.S. POCT Blood Gas and Electrolytes Market, 2007 32 Table 3.20: Manufacturer Market Share U.S. POCT Coagulation Market, 2007 32 Table 3.21: Manufacturer Market Share U.S. POCT Cardiac Marker Market, 2007 32 Table 3.22: Regional Comparison of Healthcare Spending for IVD for Eastern Europe 34 Table 3.23: European POCT Market, 2005-20012 34 Table 3.24: European POCT Diagnostics Market, 2007 34 Table 3.25: Top Twelve Country IVD and POC Testing Markets, 2007 35 Table 3.26: Japan POCT Market, 2005-20012 35 Table 4.1: Customized Reports Must Support CAP and JCAHO Requirements 41 Table 12.1: Products Marketed by Abbott in the Diagnostic Market 86 Table 12.2: Quidel Product Sales Distribution and Sales, 2007 142 Table 12.3: Key Products 149

Companies Mentioned

- Abaxis, Inc - Abbott Diagnostics - Accumetrics, Inc- - Accurex Biomedical, Pvt-, Ltd- - Akers Bioscience (ABI) - Alfa Scientific Design, Inc- - Ambri, Ltd- - American Bio Medica Corp- - Ani Biotech - Apogent Technologies - Ark Therapeutics - ARKRAY - Atlas Genetics - Atonomics - Avox Systems - Axis-Shield - Bayer Corp- - Beacon Diagnostics - Beckman Coulter - Binax Corporation - Biomerica - BioMérieux Vitek, Inc- - BioScan Screening Systems, Inc- - Biosite Diagnostics - BioStar - British Biocell Holdings - Caliper Life Sciences - Calypte Biomedical - Cardiovascular Diagnostics - Chembio Diagnostics - Cholestech - CompuCyte Corporation - Cozart Bioscience - Cygnus Therapeutic Systems - Cytogen - Dade Behring - Daiichi Sankyo Group - Denka Seiken Co-, Ltd- - Diagnostic Chemicals, Ltd- - EY Laboratories, Inc- - Enterix, Inc- - Focus Diagnostic, Inc- - GDS Technology - GenBio - Genzyme Diagnostics - Grant Life Sciences, Inc- - Gryphus Diagnostics, LLC - Guided Therapeutics, Inc - Helena Laboratories - Hema Diagnostic Systems - HemoCue, Inc- - Home Access Health Corp- - i-STAT Corporation - ImmunoScience, Inc- - Instrumentation Laboratory - International Medical Innovations - Inverness Medical Innovations - Johnson & Johnson - LifeAssays - LifePoint, Inc- - Lifestream Technologies - LXN Corp- (Inverness Medical Technologies) - Matritech - Medical Services International, Inc- - MediSense - Medisys - Medix Biochemica - MedMira Laboratories - Meretek Diganostics Group - Meridian Bioscience - MiniMed - Mitsubishi Chemical USA, Inc- - Mitsubishi Kagaku Iatron - Nanogen - New Horizons Diagnostics - Nova Biomedical - OraSure - Orgenics - Orion Diagnostica - PanBio, Ltd- - Phamatech Corporation - PharmaNetics, Inc- - Phillips Medical Systems - Polymedco - Polymer Technology Systems - Princeton BioMeditech Corporation - Quest Diagnostics - Quidel - Radiometer - Response Biomedical Corp- - Roche Diagnostics - Royal Philips Electronics - Saliva Diagnostics - Savyon Diagnostics - Selfcare, Inc- - Shanghai Siic Kehua Biotech Co-, Ltd- (Kehua Biotech) - Shionogi & Co-, Ltd- - Siemens Corporation - SpectRx, Inc- - Spectral Diagnostics - StatSure Diagnostics - STC Technologies - Strategic Diagnostics - Sun Biomedical Laboratories - Sybron International Corporation - TheraSense, Inc- - Thermo BioStar - Thoratec/International Technidyne Corp- - Trinity Biotech, PLC - Väsamed, Inc- - Venkateshwara Hatcheries Pvt-, Ltd- - Wampole Laboratories - Worldwide Medical Corporation